Type 2 Diabetes Mellitus
Conditions
Keywords
exenatide, glargine, aspart 30
Brief summary
Efficacy and Safety of Basal Insulin Glargine Combination with Exenatide bid vs Switching Premix Human Insulin to Aspart30 in T2DM with Inadequate Glycaemic Control on Premixed Human Insulin and Metformin: a Randomized, Open, Parallel trial.
Detailed description
This is a multicentre, open-label, randomized and parallel trial that will compare the efficacy and safety of basal insulin glargine combination with Exenatide bid vs. switching premix human insulin to aspart30 in type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin. Approximately 248 patients will be enrolled in the study from China and randomized in a 1:1 ratio to one of the 2 treatment arms: once-daily insulin glargine + twice-daily exenatide + metformin; or twice-daily aspart 30 + metformin. Study treatment will continue for 24 weeks. The primary efficacy measure is the change in HbA1c at 24 weeks. The study consists of 3 periods: a 1-week screening (period A), a 12-week run-in period (period B) and a 24-week treatment period (period C).
Interventions
DRUGglargine + exenatide
glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily)
DRUGaspart 30
aspart 30 ( subcutaneous injection, twice daily)
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent * Type 2 diabetic patients receiving twice-daily premixed human insulin 30 therapy ≥ 30 U/d and metformin with maximum tolerated dosage (≤ 1500mg/d) * HbA1c \> 8.0 % and \< 11.0 % (HbA1c \> 7.0 % and \< 10.0% at randomization) * Men and women (non-pregnant and using a medically approved birth-control method) aged ≥ 18 and ≤ 70 years * BMI ≥ 23 and ≤ 35 kg/m2
Exclusion criteria
* Type 1 diabetes or other specific types of diabetes * Pregnancy, preparation for pregnancy, lactation and women of child-bearing age incapable of effective contraception methods * Uncooperative subject because of various reasons * Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) \> twice the upper limits of normal * Impairment of renal function, serum creatinine: ≥ 133mmol/L for female，≥ 135mmol/L for male * Serious chronic gastrointestinal diseases * Edema * Serious heart diseases, such as cardiac insufficiency (level III or more according to NYHA), acute coronary syndrome and old myocardial infraction * Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg * White blood count (WBC) \< 4.0×109/L or platelet count (PLT) \< 90×109/L，or definite anemia (Hb：\< 120g/L for male, \< 110g/L for female), or other hematological diseases * Endocrine system diseases, such as hyperthyroidism and hypercortisolism * Experimental drug allergy or frequent hypoglycemia * Psychiatric disorders, drug or other substance abuse * Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy * Stressful situations such as surgery, serious trauma and so on * Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease * Combined use of drugs effecting glucose metabolism such as glucocorticoid * Tumor, especially bladder tumor and/or family history of bladder tumor and/or long-term hematuria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the absolute change in HbA1c from baseline to 24-week endpoint of basal insulin glargine combination with exenatide bid vs. switching to aspart30 in type 2 diabetic patients inadequately controlled on premixed human insulin and metformin. | from baseline to 24-week endpoint |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of participants who achieved HbA1c ≤ 6.5% and < 7% | 12 weeks and 24 weeks |
| Fasting blood glucose | 12 weeks and 24 weeks |
| Change in HbA1c from baseline to 12 weeks endpoint | from baseline to 12 weeks endpoint |
| Change in body weight | from baseline to 12 and 24 weeks |
| The incidence and rate of hypoglycaemic events during the study | baseline, 12 weeks and 24 weeks |
| Daily insulin use | baseline, 12 weeks and 24 weeks |
Countries
China
Outcome results
None listed